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FDA 510(k)

SBP DENTAL UNIT

K-Number: K934436 · 1994-06-02

ApplicantNorthland Dental Engineering
Decision Date1994-06-02
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SBP DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Northland Dental Engineering. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K934436. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBP DENTAL UNIT?

SBP DENTAL UNIT is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Northland Dental Engineering. The 510(k) number is K934436.

When did SBP DENTAL UNIT receive FDA 510(k) clearance?

SBP DENTAL UNIT received FDA 510(k) clearance on 1994-06-02, under 510(k) number K934436.

Who is the listed applicant for SBP DENTAL UNIT?

The FDA 510(k) record lists Northland Dental Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SBP DENTAL UNIT?

The FDA product code for SBP DENTAL UNIT is EIA.

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Related Devices (Code: EIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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